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IV Fat Emulsions

INTRALIPID 20% (A 20% Intravenous Fat Emulsion) and INTRALIPID 30% (A 30% Intravenous Fat Emulsion)

Indications

INTRALIPID 20% ( A 20% Intravenous Fat Emulsion) is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for more than 5 days) and as a source of essential fatty acids for prevention of Essential Fatty Acid Deficiency (EFAD).

INTRALIPID 30% (A 30% Intravenous Fat Emulsion) Pharmacy Bulk Package is indicated for use in a pharmacy admixture program for the preparation of three-in-one or total nutrient admixtures to provide a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for more than 5 days) and as a source of essential fatty acids for prevention of Essential Fatty Acid Deficiency (EFAD).

Important Risk Information

Deaths in preterm infants after infusion of intravenous fat emulsion have been reported in the medical literature. Autopsy findings included intravascular fat accumulation in the lungs. Treatment of premature and low birth weight infants with intravenous fat emulsion must be based upon careful benefit-risk assessment. Strict adherence to the recommended total daily dose is mandatory; hourly infusion rate should be as slow as possible in each case and should not in any case exceed 1 g fat/kg in 4 hours. Premature and small for gestational age infants have poor clearance of intravenous fat emulsion and increased free fatty acid plasma levels following fat emulsion infusion; therefore, serious consideration must be given to administration of less than the maximum recommended doses in these patients in order to decrease the likelihood of intravenous fat overload. The infant’s ability to eliminate the infused fat from the circulation must be carefully monitored (such as serum triglycerides and/or plasma free fatty acid levels). The lipemia must clear between daily infusions.

INTRALIPID 20% AND 30% PHARMACY BULK PACKAGE IS NOT INTENDED FOR DIRECT INTRAVENOUS ADMINISTRATION. DILUTING INTRALIPID 30% TO A 10% OR 20% CONCENTRATION WITH AN IV FLUID DILUENT DOES NOT PRODUCE A DILUTION THAT IS EQUIVALENT IN COMPOSITION TO INTRALIPID 10% OR 20% IV FAT EMULSIONS AND SHOULD NOT BE GIVEN BY DIRECT IV ADMINISTRATION (FOR EXAMPLE, THROUGH A Y CONNECTOR).

  • The administration of INTRALIPID 20% and INTRALIPID 30% is contraindicated in patients with disturbances of normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipidemia.
  • Exercise caution when administering INTRALIPID 20% and INTRALIPID 30% to patients with severe liver damage, pulmonary disease, anemia or blood coagulation disorders, or when there is danger of fat embolism.
  • INTRALIPID 20% and INTRALIPID 30% contains no more than 25 mcg/L of aluminum. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
  • Monitor serum triglycerides to determine the patient’s capacity to eliminate the infused fat from the circulation. Overdosage must be avoided. During long-term intravenous nutrition with INTRALIPID 20% or INTRALIPID 30%, liver function tests should be performed and therapy withdrawn if the liver becomes impaired.
  • Frequent (some advise daily) platelet counts should be done in neonatal patients receiving parenteral nutrition with INTRALIPID 20% or INTRALIPID 30%.
  • Frequent adverse events include sepsis due to contamination of the IV catheter or vein irritation may result in thrombophlebitis by concurrently infused hypertonic solutions. These adverse reactions are inseparable for the hyperalimentation procedure with or without INTRALIPID 20% or INTRALIPID 30%. Less frequent adverse reactions reported <1% in clinical trials are:
    – Immediate or early: dyspnea, cyanosis, allergic reactions, hyperlipemia, hypercoagulability, nausea, vomiting, headache, flushing, increase in temperature, sweating, sleepiness, pain in the chest and back, slight pressure over the eyes, dizziness, and irritation at the site of infusion and rarely thrombocytopenia in neonates.
    – Delayed: hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leukopenia, transient increases in liver function tests, and overloading syndrome (focal seizures, fever, leukocytosis, hepatomegaly, splenomegaly and shock).
    – The deposition of a brown pigmentation in the reticuloendothelial system called “intravenous fat pigment” has been reported. The causes and significance are unknown.
  • INTRALIPID 30% PHARMACY BULK PACKAGE IS NOT INTENDED FOR DIRECT INTRAVENOUS ADMINISTRATION. DILUTING INTRALIPID 30% TO A 10% OR 20% CONCENTRATION WITH AN INTRAVENOUS FLUID SUCH AS NORMAL SALINE OR OTHER DILUENT DOES NOT PRODUCE A DILUTION THAT IS EQUIVALENT IN COMPOSITION TO INTRALIPID 10% OR 20% I.V. FAT EMULSIONS, AND SUCH A DILUTION SHOULD NOT BE GIVEN BY DIRECT INTRAVENOUS ADMINISTRATION. (FOR EXAMPLE, THROUGH A Y-CONNECTOR).
  • The administration of INTRALIPID 20% and INTRALIPID 30% is contraindicated in patients with disturbances of normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipidemia.
  • Exercise caution when administering INTRALIPID 20% and INTRALIPID 30% to patients with severe liver damage, pulmonary disease, anemia or blood coagulation disorders, or when there is danger of fat embolism.
  • INTRALIPID 20% and INTRALIPID 30% contains no more than 25 mcg/L of aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
  • Monitor serum triglycerides to determine the patient’s capacity to eliminate the infused fat from the circulation. Overdosage must be avoided. During long-term intravenous nutrition with INTRALIPID 20% or INTRALIPID 30%, liver function tests should be performed and therapy withdrawn if the liver becomes impaired.
  • Frequent (some advise daily) platelet counts should be done in neonatal patients receiving parenteral nutrition with INTRALIPID 20% or INTRALIPID 30%.
  • Frequent adverse events include sepsis due to contamination of the IV catheter and vein irritation may result in thrombophlebitis by concurrently infused hypertonic solutions. These adverse reactions are inseparable from the hyperalimentation procedure with or without INTRALIPID 20% or INTRALIPID 30%. Less frequent adverse reactions reported <1% in clinical trials are:
  • Immediate or early: dyspnea, cyanosis, allergic reactions, hyperlipemia, hypercoagulability, nausea, vomiting, headache, flushing, increase in temperature, sweating, sleepiness, pain in the chest and back, slight pressure over the eyes, dizziness, and irritation at the site of infusion and rarely thrombocytopenia in neonates.
  • Delayed: hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leukopenia, transient increases in liver function tests, and overloading syndrome (focal seizures, fever, leukocytosis, hepatomegaly, splenomegaly and shock).
  • The deposition of a brown pigmentation in the reticuloendothelial system called “intravenous fat pigment” has been reported. The causes and significance are unknown.

Please see full prescribing information, including Boxed Warning

USMP/78/14-0015